BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3220069 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04692
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    April 24, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF NOISE COULD NOT BE REPRODUCED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, NOISE WAS OBSERVED ON THE ATRIAL AND VENTRICULAR CHANNELS. THE PHYSICIAN SUSPECTS A DEVICE HEADER ISSUE. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320346 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1